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Abstract:

An anchor for maintaining a portion of a therapy delivery element within
a desired location of a patient has (i) a first opening, (ii) a second
opening, (iii) a body member formed of elastic material disposed between
the first and second opening, (iv) and a lumen extending though the body
member from the first opening to the second opening, and (v) a retention
element secured to or integrally formed with the body member for
retaining the anchor within a tissue location of a patient. The therapy
delivery element has an outer diameter and an outer surface about which
the anchor is disposable. The body member has a first inner diameter
defined by the lumen in a relaxed state and a second inner diameter
defined by the lumen in a radially stretched state. The first inner
diameter is smaller than the outer diameter of the therapy delivery
element, which is smaller that the second inner diameter. The lumen is
configured to be disposed about at least a portion of the therapy
delivery element. Radially compressive forces, due to the elastic
material of the body member, contribute to retaining the anchor relative
to the therapy delivery element.

Claims:

1. (canceled)

2. An anchor deployment apparatus, comprising: an anchor receiving
element including an elongate member defining a first opening, a second
opening, and a lumen extending from the first opening to the second
opening, wherein the lumen is configured to slidably receive at least a
portion of a therapy delivery element; and an anchor engagement element
defining (i) an anchor engagement element having a face, and (ii) a
channel extending through the anchor engagement element proximally from
the face, wherein a width of the channel at the face is sufficiently
small to engage an anchor disposed about the elongate member of the
anchor receiving element when the elongate member is moved proximally
relative to the face.

3. The apparatus of claim 2, further comprising a handle positioned
generally perpendicular to a longitudinal axis of the elongate member.

4. A kit comprising: an anchor having a body member and a retention
element secured to or integrally formed with the body member, wherein the
body member defines (i) a first opening, (ii) a second opening, and (iii)
a lumen extending from the first opening to the second opening, and an
anchor deployment apparatus according to claim 2, wherein the lumen of
the anchor is configured to receive the elongate member of the anchor
receiving element.

5. The kit of claim 4, wherein the body member of the anchor is formed
from elastic material, wherein the lumen of the body member of the anchor
is configured to be disposed about at least a portion of the outer
surface of a therapy delivery element, and wherein at least a portion of
the body member of the anchor has a first inner diameter defined by the
lumen in a relaxed state and a second inner diameter defined by the lumen
in a radially stretched state, the first inner diameter being smaller
than the second inner diameter.

6. The kit of claim 4, wherein the anchor is preloaded about the elongate
member of the anchor receiving element.

7. The kit of claim 4, wherein the body member of the anchor is formed
from silicone.

8. The kit of claim 4, further comprising the therapy delivery element.

9. The kit of claim 4, wherein the therapy delivery element is a
catheter.

10. The kit of claim 4, wherein the therapy delivery element is a lead.

Description:

RELATED APPLICATIONS

[0001] This application is a continuation application of U.S. application
Ser. No. 14/105,393, filed on Dec. 13, 2013 and to issue as U.S. Pat. No.
9,005,168 on Apr. 14, 2015, which is a continuation of U.S. application
Ser. No. 13/548,003, filed Jul. 12, 2012 and issued as U.S. Pat. No.
8,613,729 on Dec. 24, 2013, and which is a continuation of U.S. patent
application Ser. No. 12/056,547, filed Mar. 27, 2008 and issued as U.S.
Pat. No. 8,262,624 on Sep. 11, 2012, which applications are hereby
incorporated herein by reference.

FIELD

[0002] This disclosure relates, inter alia, to implantable medical
devices. More particularly, it relates to anchors, anchor deployment
apparatuses, and methods for retaining a therapy delivery element, such
as a catheter or lead, relative to a position of a patient in which the
element is implanted.

BACKGROUND

[0003] Implantable medical catheters and leads have been employed for a
variety of therapeutic and diagnostic purposes. Controlled placement of
such therapy delivery elements within in a patient is highly desirable,
as precise placement may result in improved therapeutic efficacy or
reduced side effects. However, the location of the delivery element may
change in time. As the patient moves, the location of the implanted
delivery element may move.

[0004] Anchors, which are typically placed about the delivery element and
sutured to subcutaneous tissue of the patient, are employed to secure the
position of a delivery region, e.g. infusion section or electrode, of the
delivery element; e.g. catheter or lead, relative to a target location of
the patient. However, existing anchors may suffer from one or more
drawbacks, including (i) ineffective gripping of an implanted therapy
delivery element when subjected to stresses associated patient movement,
(ii) awkward techniques for placing the anchor about the delivery element
or for suturing the anchor to tissue, and (iii) susceptibility damage
during suturing.

SUMMARY

[0005] The present disclosure describes, inter alia, anchors, anchor
deployment apparatuses, kits, systems and methods that provide for
effective gripping of a therapy delivery element, simple delivery of an
anchor, or protection of the delivery element during suturing.

[0006] In an embodiment, an anchor for maintaining a portion of a therapy
delivery element within a desired location of a patient is described. The
therapy delivery element has an outer diameter and an outer surface about
which the anchor is disposable. The anchor includes (i) a first opening,
(ii) a second opening, (iii) a body member formed from elastic material
disposed between the first and second opening, (iv) a lumen extending
though the body member from the first opening to the second opening, and
(v) a retention element secured to or integrally formed with the body
member for retaining the anchor within a tissue location of a patient.
The lumen is configured to be disposed about at least a portion of the
outer surface of the therapy delivery element. At least a portion of the
body member has a first inner diameter defined by the lumen in a relaxed
state and a second inner diameter defined by the lumen in a radially
stretched state. The first inner diameter is smaller than the second
inner diameter. The first inner diameter is configured to be smaller than
the outer diameter of the therapy delivery element, and the second inner
diameter is configured to be larger than the outer diameter of the
therapy delivery element.

[0007] In an embodiment, an anchor deployment apparatus for deploying an
anchor about a therapy delivery element is described. The anchor
deployment apparatus includes an anchor receiving element having an
elongate member with a distal opening and a lumen extending proximally in
the elongate member from the distal opening. The lumen of the elongate
member is configured to slidably receive at least a portion of a therapy
delivery element. The anchor deployment apparatus further includes an
anchor engagement element having (i) a first channel in which the
elongate member of the anchor receiving element is axially movable, and
(ii) an engagement feature forming at least a part of the channel. The
engagement feature is configured to engage the anchor when the anchor is
disposed about the elongate member and the elongate member is moved
distally relative to the engagement element, and to cause the anchor to
move distally along the elongate member when the feature is engaged with
the anchor and the elongate member is moved distally relative to the
engagement element.

[0008] In an embodiment, a system is described. The system includes an
anchor having a first opening, a second opening, a body member disposed
between the first and second opening, and a lumen extending though the
body member from the first opening to the second opening. The body member
is formed from an elastic material, and at least a portion of the body
member has a first inner diameter defined by the lumen in a relaxed state
and a second inner diameter defined by the lumen in a radially stretched
state. The first inner diameter is smaller than the second inner
diameter. The system further includes a therapy delivery element having
an outer diameter and an outer surface about which the anchor is
disposable. The outer diameter is larger than the first inner diameter of
the at least a portion of the lumen of the anchor and smaller than the
second inner diameter of the at least a portion of the lumen of the
anchor. The system also includes an anchor deployment apparatus including
an anchor receiving element. The anchor receiving element has an elongate
member with a distal opening and a lumen extending proximally in the
elongate member from the distal opening. The lumen of the elongate member
is configured to slidably receive at least a portion of the therapy
delivery element. The elongate member has an outer diameter larger than
the first inner diameter of the at least a portion of the lumen of the
anchor and smaller than the second inner diameter of the at least a
portion of the lumen of the anchor such that the anchor is disposable
about the elongate member and, when the anchor is disposed about the
elongate member, the at least a portion of the lumen of the anchor
engages at least a portion of the elongate member. The anchor is moveable
about the elongate member and deployable about the therapy delivery
element.

[0009] By providing anchors, anchor deployment apparatuses, kits, systems
and methods that provide for effective gripping of a therapy delivery
element, simple delivery of an anchor, or protection of the delivery
element during suturing, therapeutic efficacy may be enhanced or
complications may be reduced. These and other advantages will be readily
understood from the following detailed descriptions when read in
conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 is a schematic drawing of a diagrammatic representation of a
perspective view of an environment of an implantable medical system in a
patient.

[0011] FIGS. 2A-D are schematic drawings of diagrammatic representations
of perspective views of environments of medical devices implanted in
patients.

[0012] FIG. 3A is a schematic drawing of a top view of an anchor.

[0013] FIG. 3B is a schematic drawing of a cross-section of the anchor in
FIG. 3a taken through line 3b-3b.

[0014] FIGS. 3C-D are schematic drawings of head on back and front views
of the anchor of FIG. 3A, as viewed along lines 3c and 3d, respectively.

[0015] FIG. 4A is a schematic drawing of a top view of a representative
system including an anchor, anchor receiving element, and a therapy
delivery element.

[0016] FIG. 4B is a schematic drawing of a cross section taken through
line 4b-4b of FIG. 4A.

[0017] FIG. 4C is a schematic drawing of an exploded top view of the
system of FIG. 4A.

[0018] FIGS. 4D-E are a schematic drawings of head on front and back views
of the anchor receiving element depicted in FIG. 4c as viewed along lines
4d and 4e, respectively.

[0019] FIGS. 5A-B are schematic drawings of a representative system
showing deployment of an anchor from about an anchor receiving element to
about a therapy delivery element.

[0020] FIG. 5C is a schematic drawing of a cross section of an anchor
disposed about a therapy delivery element taken along line 5c-5c of FIG.
5B.

[0021] FIG. 6A is a schematic drawing of a top view of a system including
an anchor, a therapy delivery element, and an anchor deployment apparatus
that includes an anchor receiving element and an anchor engagement
element.

[0022] FIG. 6B is a schematic drawing of an exploded top view of the
system depicted in FIG. 6A.

[0023] FIG. 6C is a schematic drawing of an exploded side view of the
anchor engagement element and anchor receiving element shown in FIG. 6A.

[0024] FIG. 6D is a schematic drawing of an opposing side view (relative
to FIG. 6C) of the anchor engagement element shown in FIG. 6C.

[0025] FIG. 6E is a schematic drawing of a cross section taken along line
6e-6e of FIG. 6A.

[0026] FIG. 6F is a schematic drawing of a cross section taken along line
6f-6f of FIG. 6A.

[0027] FIG. 6G is a schematic drawing of an alternative embodiment of a
cross section taken along line 6e-6e of FIG. 6A.

[0028] FIGS. 7A-C are schematic diagrams of top views of a system showing
an anchor engagement element employed to move an anchor along an anchor
receiving element and onto and about a therapy delivery element.

[0029] FIG. 8 is a schematic drawing of a side view of a longitudinal
section taken along line 8-8 of FIG. 7B.

[0030] FIG. 9A is a schematic diagram of a side view of an anchor
engagement element.

[0031] FIG. 9B is a schematic drawing of a top view of a longitudinal
section of the anchor engagement element taken at line 9b-9b of FIG. 9A.

[0032] FIG. 10 is a schematic drawing of a top view of components of a
kit.

[0033] FIGS. 11A-C are schematic drawings of top views of a system
including an anchor, an insertion element, and an anchor receiving
element.

[0034] FIG. 12 is a cross section of an anchor diposed about an insertion
element taken along line 12-12 of FIG. 11.

[0035] The drawings are not necessarily to scale. Like numbers used in the
figures refer to like components, steps and the like. However, it will be
understood that the use of a number to refer to a component in a given
figure is not intended to limit the component in another figure labeled
with the same number. In addition, the use of different numbers to refer
to components is not intended to indicate that the different numbered
components cannot be the same or similar.

DETAILED DESCRIPTION

[0036] In the following detailed description, reference is made to the
accompanying drawings that form a part hereof, and in which are shown by
way of illustration several specific embodiments of devices, systems and
methods. It is to be understood that other embodiments are contemplated
and may be made without departing from the scope or spirit of the present
invention. The following detailed description, therefore, is not to be
taken in a limiting sense.

[0037] All scientific and technical terms used herein have meanings
commonly used in the art unless otherwise specified. The definitions
provided herein are to facilitate understanding of certain terms used
frequently herein and are not meant to limit the scope of the present
disclosure.

[0038] As used herein, "diameter" means a cross sectional distance from
one location of a structure to a generally opposition location of the
structure, and is not necessarily limited to circular cross sections. For
example, a lumen may have a square, circular, oval, rectangular, or any
other cross-sectional shape. Accordingly, it will be understood that
"radially stretchable" means expandable such that a cross-sectional area
is increasable, and is also not limited to cylindrically shaped
structures.

[0039] As used in this specification and the appended claims, the singular
forms "a", "an", and "the" encompass embodiments having plural referents,
unless the content clearly dictates otherwise. As used in this
specification and the appended claims, the term "or" is generally
employed in its sense including "and/or" unless the content clearly
dictates otherwise.

[0040] The present disclosure describes, inter alia, anchors, anchor
deployment apparatuses, kits, systems and methods that provide for
effective gripping of a therapy delivery element, simple delivery of an
anchor, or protection of the delivery element during suturing.

[0041] Referring to FIG. 1, a general representative environment for an
implanted medical device 1 and therapy delivery element 20 are shown.
Medical device 1, such as a pacemaker, defibrillator, monitoring device,
infusion device, neurostimulator, gastric stimulator, cochlar device, or
the like, is subcutaneously implanted in a patient, for example in an
abdominal region. A distal portion 22 of therapy delivery element 20 is
positioned in the patient at a location where therapy is desired to be
delivered. In the embodiment depicted, the distal portion 22 of therapy
delivery element 20 is positioned within or along a spinal canal or cord
of a patient. However, it will be understood that distal portion 22 of
therapy delivery element 20 may be placed in any desired location to
achieve its intended purpose, such as a diagnostic, monitoring, or
therapeutic purpose. In the depicted embodiment, proximal end 24 of
therapy delivery element 20 is operably coupled to medical device 1.

[0042] In FIG. 1, an anchor 10 is shown disposed about therapy delivery
device 20. The depicted anchor 10 contains suture holes 18 for suturing
the anchor 10 to tissue of the patient to maintain the position of the
therapy delivery element 20 in proximity to the anchor 10 relative to a
location of the patient.

[0043] Therapy delivery element 20 may be a catheter, a lead or lead
extension, or the like. In numerous embodiments, therapy delivery element
20 is an elongate element that can deliver therapy, withdraw fluid, sense
a parameter, or diagnose a condition. Catheters are typically flexible
tubes with a lumen running from the proximal end of the catheter to one
or more delivery regions that are typically located at the distal portion
of catheter. A proximal end of a catheter may be coupled to an infusion
medical device 1 such that fluid may be delivered from the device 1 via
the lumen of the catheter to a target location of a patient via one or
more delivery regions of the catheter.

[0044] Leads typically include one or more electrical contacts on a
proximal end portion and one or more electrodes on a distal end portion.
The contacts and electrodes are electrically coupled via insulated wires
running through the lead. The contacts may be electrically coupled with
an electrical signal generator medical device 1, and signals generated by
the device 1 may be carried along the lead and delivered to the patient
via the electrodes. A lead may be connected to a signal generator medical
device 1 through a lead extension. An extension typically includes one or
more contacts at the proximal and distal end portions that are
electrically coupled through wires running through extension. Of course
it will be understood that with some systems a lead may be directly
connected to electrical signal generator medical device 1 without use of
a lead extension. As used hereinafter, "leads" and "lead extensions" are
used interchangeably, unless content clearly dictates otherwise.

[0045] Referring to FIG. 2, alternative locations for implanting a medical
device 1 are shown. As depicted in FIG. 2A, device 1 may be implanted in
the pectoral region 4 of a patient. Alternatively, device 1 may be
implanted in the head 5 of a patient, more specifically behind the
patient's ear (FIG. 2B), in the patient's abdomen 6 (FIG. 2C) or in the
patient's lower back 7 or buttocks (FIG. 2D). Of course, device 1 may be
placed in any medically acceptable location in patient.

[0046] While not shown, it will be understood that therapy delivery
element 20 may be operably coupled to an external device (not shown), as
opposed to or in addition to being operably couplable to an implantable
device 1.

[0047] Referring now to FIG. 3, schematic drawings of various views of an
embodiment of an anchor 10 are shown. As shown in the top view of FIG.
3A, anchor 10 includes a first opening 12, a second opening 14, and a
body portion 11 between the first 12 and second openings 14. The body
portion 11 is formed of elastomeric material. A lumen 15 (see FIG. 3B,
which is a schematic of a cross section taken through line 3b-3b of the
anchor depicted in FIG. 3A) extends through the body portion 11 from the
first opening 12 to the second opening 14. FIGS. 3C-D are schematics of
head on back and front views from the perspective of lines 3c and 3d (as
shown in FIG. 3A), respectively, providing a view of first 12 and second
14 openings.

[0048] Referring to FIG. 3B, at least a portion of body 11 is radially
stretchable such that the body portion 11 has a first inner diameter
(i.d. 1) (defined by the lumen 15) in a relaxed state and a second larger
inner diameter (i.d. 2) in a stretched state. As used herein, a
"stretched state" of a body portion 11 means a state where body portion
11 has a larger inner diameter (defined by lumen 15) than in a relaxed
state, and where the structural integrity of the body portion 11 is not
compromised. A structurally uncompromised body portion 11 will generally
be free of cracks or tears or will be capable of returning substantially
to its relaxed state (i.e. to an inner diameter prior to radial
stretching).

[0049] Body portion 11 of anchor 10 may be formed from any suitable
elastic material. Examples of suitable elastic materials include
copolymers of styrene-butadiene, polybutadiene, polymers formed from
ethylene-propylene diene monomers, polychloroprene, polyisoprene,
copolymers of acrylonitrile and butadiene, copolymers of isobutyldiene
and isoprene, polyurethanes and the like. In various embodiments, body
portion 11 of anchor 10 is formed of material capable of being stretched
up to about 50% or more without substantial loss of structural integrity.
For example, body portion 11 may be capable of being stretched up to
about 75% or more, 100% or more, 150% or more, or 200% or more. Silicone
an example of an elastic material that is generally expandable up to
about 100% or more without substantial loss of structural integrity.

[0050] Body portion 11 may be made from the same or different material
than the remainder of anchor 10. In various embodiments, the entire
anchor 10 is molded from the same material.

[0051] The anchor 10 depicted in FIG. 3 includes retention elements 16.
One or more holes 18 may be formed in a retention element 16 for suturing
anchor 10 to tissue of a patient. Retention element 16 may be coupled to
or attached to (generally secured to) or may be integrally formed with
body member 11. It will be understood that anchor 10 may include any
number of retention elements 16. While retention elements are shown as
extensions with suture holes 18, it will be understood that anchor 10 may
include any suitable retention element, such as barbs, tines, or the like
to retain anchor 10 with in a tissue location of a patient.

[0052] In various embodiments, body portion 11 of anchor 10 is free of
free or substantially free of slits or openings other than first 12 and
second 14 openings. In such embodiments, anchor 10, due to the elastic
nature of body member 11, may provide a uniform radially compressive
force against a therapy delivery element about which the anchor 10 is
disposed. The absence of slits or other openings may allow for improved
gripping by anchor 10 of a therapy delivery element. It will be
understood that, in various embodiments, slits or other openings in body
member 11 may be present, provided that anchor 10 is capable of
grippingly engaging a therapy delivery element with a desired retention
force.

[0053] Referring now to FIG. 4, schematic drawings of various views of an
embodiment of a system including an anchor 10, therapy delivery element
20, and an anchor receiving element 30 are shown. The anchor receiving
apparatus 30, as depicted, may serve as an anchor deployment apparatus.
FIG. 4A depicts a schematic of a top view of a representative system;
FIG. 4B is a schematic of a cross section taken through line 4b-4b of
FIG. 4A; FIG. 4C is a schematic of an exploded top view of the system
depicted in FIG. 4A; and FIGS. 4D-E are schematics of head on front and
back views of anchor receiving apparatus 30 taken along lines 4d and 4e,
respectively, of FIG. 4C. The anchor receiving apparatus 30 includes an
elongate member 36 and a distal opening 32. Elongate member forms a
cavity or lumen 35 in communication with distal opening 32. Lumen 35 is
configured to slidably receive proximal portion 24 of therapy delivery
element 20. In numerous embodiments, anchor receiving element 30 includes
a proximal opening 34 and lumen 35 extends within elongate member 36 from
the distal 32 to the proximal 34 opening. In such configurations, therapy
delivery element 20 may be slid through lumen 35 of anchor receiving
element 30 such that proximal end 24 of therapy delivery apparatus 20 may
extend beyond proximal opening 34 of anchor receiving element 30 (not
shown in FIG. 4).

[0054] As depicted in FIGS. 4A-B, anchor 10 is disposed about anchor
receiving element 30. Body member 11 of anchor 10 is disposed about and
snuggly engages an outer surface of elongate member 36 of anchor
receiving apparatus 30. Elongate member 36 of anchor receiving apparatus
30 has an outer diameter (o.d.) that is larger than the relaxed inner
diameter (i.d. 1, see FIG. 3B) defined by lumen 15 of anchor 10 and that
is smaller than a stretched inner diameter (i.d. 2, see FIG. 3B) defined
by lumen 15 of anchor 10. As such, elastic body portion 11 of anchor 10
may be radially stretched so that body portion 11 anchor 10 can be
positioned about elongate member 36 of anchor receiving element 30. The
elastic properties of the material forming body member 11 of anchor 10
allow body member 11 to snuggly engage the outer surface of elongate
member 36 of the anchor receiving element 30.

[0055] With reference to FIG. 4B, elongate body member 36 of anchor
receiving apparatus 30 defines a lumen 35. The lumen 35 is configured to
slidably receive at least a portion of therapy delivery element 20.
Therapy delivery element 20 has an outer diameter (o.d.) that is larger
than the relaxed inner diameter (i.d. 1, see FIG. 3B) defined by lumen 15
of anchor 10 and that is smaller than a stretched inner diameter (i.d. 2,
see FIG. 3B) defined by lumen 15 of anchor 10. It will be understood that
therapy delivery element 20 is depicted in FIG. 4B as solid for purposes
of illustration. If therapy delivery element 20 were a catheter, a lumen
might be depicts; if therapy delivery element 20 were a lead, an
insulated conductor might be depicted; etc.

[0056] Referring now to FIG. 5A, which is the same top view of the system
shown in FIG. 4A, except that anchor 10 is depicted as being moved
distally (in direction of arrow) along elongate body member 36 of anchor
receiving apparatus 30. Anchor 10 is slidably moveable off distal end of
elongate member 36 onto therapy delivery device 20, the proximal portion
24 of which is disposed within lumen 35 of anchor receiving element 30
(see, e.g., FIG. 4).

[0057] Anchor 10 may be moved distally about elongate member 36 and onto
therapy delivery element 20 through any acceptable manner, including by
pushing or pulling. For example, anchor 10 may be manually moved by a
physician's fingers in some embodiments. In some embodiments, anchor 10
is pushed with an anchor engagement element; e.g., as discussed below
with regard to FIGS. 6-8. When body member 11 of anchor 10 is disposed
about therapy delivery element 20, body member snuggly engages at least a
portion of the outer surface of therapy delivery element 20 (see e.g.,
FIG. 5C), due to elastic properties of body member 11 and the larger
outer diameter of therapy delivery element 20 relative to the relaxed
inner diameter of body member 11 defined by lumen 15.

[0058] Preferably, anchor body member 11 grips therapy delivery element 20
with sufficient force to prevent movement of anchor 10 relative to
therapy delivery element 20 under typical forces experienced when anchor
10 is disposed about a therapy delivery element 20 and is suture to a
patient. In various embodiments, a pull force of about 1 lbf (0.45
kilogram-force) or more is required to longitudinally move anchor 10
relative to a therapy delivery element 20 that the anchor 10 is disposed
about. For example, a pull force of about 2 pound-force (0.9
kilogram-force), about 3 pound-force (1.4 kilogram-force), about 4 pound
force (1.8 kilogram-force), about 5 pound-force (2.3 kilogram-force),
about 6 pound-pound force (kilogram-force), or more may be required to
longitudinally move anchor 10 relative to a therapy delivery element 20.
It will be understood that, in addition to the elastic properties of
anchor body member 11, other material properties of anchor body 11 and
therapy delivery element 20 may affect the pull force required to move
anchor 10 along therapy delivery element 20. For example, friction due to
various interactions may play a significant role.

[0059] In many embodiments, the pull force required to move anchor 10
about elongate member 36 of anchor receiving element 30 is less than the
pull force required to move anchor 10 about therapy delivery element 20.
This can be accomplished, despite a larger outer diameter of elongate
member 36 (relative to therapy delivery element 20) by forming elongate
member 36 from material that decreases frictional interaction between
anchor 10 and elongate member 36. For example, elongate member 36 may be
formed of higher durometer material than therapy delivery element 20. By
way of another example, elongate member 36 may be coated with a material
to reduce friction, such ethylene tetrafluoroethylene (ETFE) or
polytetrafluoroethylene (PTFE).

[0060] Elongate member 36 of anchor receiving element 30 may be made of
any suitable material. Preferably, elongate member 36 is formed from a
rigid material, such as stainless steel, titanium, polycarbonate,
polypropylene, or the like.

[0061] If anchor 10 is to be sutured to tissue of a patient, it may be
desirable to suture anchor 10 while it is disposed about elongate member
36 of anchor receiving element 30 to prevent potential damage to therapy
delivery element 20 due to accidental piercing of therapy delivery
element 20 with a suture needle. Further, anchor receiving element 30,
due to the rigidity of elongate member 36, allows for an implanting
physician to maintain the location of anchor 10 with one hand and to
suture anchor 10 with the other hand. If anchor 10 is sutured to tissue
while disposed about anchor receiving element 30, at least the proximal
portion 24 of the therapy delivery element 20 will preferably be disposed
within lumen 35 of elongate member 36 to allow transfer of anchor 10 from
anchor receiving element 30 to therapy delivery element 20.

[0062] Referring now to FIG. 6, schematic drawings of various views of an
embodiment of a system are shown. The system includes an anchor
engagement element 40 and an anchor receiving element 30, collectively
referred to as an anchor deployment apparatus, an anchor 10 and a therapy
delivery element 20. FIG. 6A is a top view of the system; FIG. 6B is an
exploded top view of the system depicted in FIG. 6B; FIG. 6C is an
exploded side view of an embodiment of an anchor engagement element 40
and anchor receiving element 30 depicted in FIG. 6A; FIG. 6D is an
opposing side view (relative to FIG. 6C) of anchor engagement element 40;
FIG. 6E is a cross section taken along line 6e-6e of FIG. 6A, FIG. 6F is
a cross section taken along line 6f-6f of FIG. 6A; and FIG. 6G is a an
alternative embodiment (relative to FIG. 6E) of a cross section taken
along line 6e-6e of FIG. 6A. In the embodiment depicted in FIGS. 6A-C,
anchor receiving element 30 includes a handle 38 at proximal end of
elongate member 36. Handle 38 is positioned generally perpendicular to
the longitudinal axis of elongate member 36. The anchor receiving element
30 including handle 38 may contain a proximal opening 34 such that lumen
35 extends within elongate member 36 from proximal opening 34 to distal
opening 32. Handle 38 may be made from the same or different material
than elongate body 36.

[0063] Referring to FIGS. 6C-F, anchor engagement element 40 has a
proximal opening 42. In proximity to or adjacent to the opening 42, the
engagement element 40 contains an anchor engagement feature 41. The
proximal opening 42 is in communication with a channel 45 formed within
the body of the element 40. The channel 45 runs generally longitudinally
within at least a proximal portion of engagement element 40. Channel 45
is configured such that at least a distal portion of elongate member 36
of anchor receiving element 30 may be slidably disposed within channel
45. In the depicted embodiment, a larger second channel 46 is formed
within engagement element 40. The second channel 46 is in communication
with and an extension of the first channel 45. On a side of engagement
element 40 generally opposing the opening of the second channel 45, a
slot 48 is formed within the body of the element 48. The slot 48 and the
second channel 46 form an uninterrupted passageway through the engagement
element 40. The passageway formed by the slot 48 and second channel 46 is
configured such that handle 38 of anchor receiving element 30 is slidably
disposable within the passageway. When anchor receiving element 30 is
slidably disposed with anchor engagement element 40, a portion of either
side of handle 38 of receiving element 30 extends beyond the body of
engagement element 40.

[0064] Referring to the alternative embodiments depicted in FIG. 6G,
channel 45 may be tapered inwardly to facilitate insertion of elongate
member 36 of receiving element 30 into channel 45. In the embodiments
depicted in FIGS. 6C, 6E and 6G, enagement feature 41 defines channel 45
and defines opening 42. The radial dimensions of the channel 45 may be
larger or substantially the same as the outer diameter of the elongate
member 36.

[0066] Referring to FIG. 8, which is schematic of a side view of a
longitudinal section taken along line 8-8 of FIG. 7B, anchor engagement
element 40 is shown in contact with anchor 10. Engagement feature 41 of
engagement element 40 is configured to interact with at least a portion
of anchor 10 such that engagement feature 41 is capable of moving anchor
10 distally along elongate member 36 of anchor receiving element 30 when
engagement element is moved distally relative to elongate member 36 of
anchor receiving element 30. In the embodiment depicted in FIG. 8, and as
discussed above with regard to FIGS. 6C, 6E and 6G, engagement feature 41
defines channel 45 and proximal opening 42 of engagement element 40. The
opening 42 defined by engagement feature 41, in the depicted embodiments,
has dimensions that are smaller than at least a portion of the outer
diameter of the body member 11 of the anchor 10.

[0067] The anchor deployment tools depicted in FIGS. 6-8 allows for kits
having multiple anchor receiving elements 30 with preloaded anchors 10 to
be provided with a single anchor engagement element 40. An anchor
receiving element 30 may readily be inserted and withdrawn from
engagement element 40, allowing for re-insertion of the same or another
anchor receiving element 30. However, embodiments where anchor receiving
element 30 is not removable and reinsertable into anchor engagement
element 40 are envisioned.

[0068] Referring now to FIG. 9A, a schematic drawing of a side view of an
embodiment of an anchor engagement element 40 is shown. The engagement
element 40 may include one or more stop features 49 protruding into the
passageway formed by slot 48 and second channel 46 (see, e.g., FIGS. 6C,
6D and 6F). The stop features 49 are configured and positioned engage a
handle 38 of an anchor receiving element 30 (see, e.g., FIGS. 6-8) and,
once engaged, to prevent further proximal movement of handle 38 within
the opening formed by the slot and second channel of engagement element
40. The engagement element 40 may further include a deflecting element 47
extending in the passageway formed by the slot 48 and second channel 46
and configured to deflect proximal end 24 of therapy delivery element 20
(see, e.g., FIG. 8) in embodiments where therapy delivery element 20 may
extend beyond a proximal portion or handle 38 of anchor receiving element
30.

[0069] Referring to FIG. 9B, in which a schematic drawing of a top view of
a longitudinal section taken at line 9b-9b of FIG. 9A is shown,
deflecting element 47, in the depicted embodiment, is wedge shaped and is
capable of causing deflection of an end portion of a therapy delivery
element that is advanced proximally within a lumen of an anchor receiving
element that is disposed with the anchor engagement element 40 to deflect
out of a side (e.g., slot 48 or channel 46) of the engagement element 40
to prevent backing up of therapy delivery element 20 and to allow for
relatively proximal movement of therapy delivery element with in the
context of the systems described herein.

[0070] Anchor engagement element 40 may be formed from any suitable
material. Preferably the body of engagement element 40 is formed from a
rigid material, such as stainless steel, titanium, polycarbonate,
polypropylene, or the like. In various embodiments, the body of
engagement element 40 is formed of a polymer having a durometer of about
75D or higher. In various embodiments, engagement element 40 is molded in
its entirety.

[0071] Referring to FIG. 10, a schematic drawing of a top view of
representative components of a kit is shown. A kit may include an anchor
engagement element 40, an anchor 10, and an anchor receiving element 30.
The anchor 30 may be preloaded on the anchor receiving element 30. In
various embodiments, a kit includes two or more anchor receiving elements
30 with preloaded anchors 10. In the depicted embodiment, the anchor
receiving elements 30 are insertable, removable and reinsertable in the
anchor engagement element 40. An anchor receiving element 30 may be
preloaded in anchor engagement element 40. A kit may further include a
therapy delivery element (not shown in FIG. 11).

[0072] Anchor 10 may be loaded on anchor receiving element 30 in any
manner that retains the elastic and therapy delivery element-retaining
properties of the anchor. One suitable manner for placing anchor 10 about
anchor receiving element 30 is shown in FIGS. 11A-C. As shown in FIG.
11A, anchor 10 may be placed about an insertion element 50 having
proximal 54 and distal 52 ends. A handle (not shown) may be attached to
or form a part of a distal portion of insertion element 50. Proximal end
54 of insertion element 50 may be inserted into a lumen of anchor
receiving element 30 via proximal opening 32 (see FIG. 11B), and anchor
10 may be moved proximally along insertion element 50 and about receiving
element 30 until anchor 10 is entirely disposed about elongate member 36
of receiving element 30 (FIG. 11C). As shown in FIG. 12, which is
schematic cross section taken through line 12-12 of FIG. 11B, insertion
element 50 has an outer diameter (o.d.). The outer diameter (o.d.) is
larger than the relaxed inner diameter of anchor body 11 and smaller than
a radially stretched inner diameter of anchor body 11 (see FIG. 3B). The
outer diameter (o.d.) of insertion element 50 is sized to cause some
radial expansion of anchor body 11 when anchor 10 is disposed about
insertion element 50, but preferably not too much to prevent sliding of
anchor 10 about insertion element 50. Insertion element 50 outer diameter
(o.d.) is preferably only slightly smaller than the inner diameter (i.d.)
of elongate body 36 of receiving member 30 so that when anchor 10 is
transferred, via sliding, from insertion element 50 to receiving element
30, lumen 15 extending through anchor body 11 (see FIG. 3B) does not
undergo substantial radial expansion, as substantial radial expansion of
anchor body 11 may make it difficult to transfer anchor 10 due to the
elastic properties of anchor body 11.

[0073] Insertion element 50 is preferably formed from a rigid material,
such as stainless steel, titanium, polycarbonate, polypropylene, or the
like. In various embodiments, insertion element 50 is formed of a polymer
material having a durometer of about 75D or higher.

[0074] Thus, embodiments of ANCHOR AND ANCHOR DEPLOYMENT APPARATUS are
disclosed. One skilled in the art will appreciate that the present
invention can be practiced with embodiments other than those disclosed.
The disclosed embodiments are presented for purposes of illustration and
not limitation, and the present invention is limited only by the claims
that follow.